Actos® / Bladder Cancer Lawsuits
Nationwide Legal Investigation into Problems with Actos®
The FDA and the European Medicines Agency (EMA) have issued urgent safety alerts regarding the Type-2 Diabetes drug Actos® (pioglitazone). Analysis of clinical studies in the United States and Europe has revealed an increased risk of bladder cancer among patients prescribed the diabetes drug Actos®.
The FDA's Actos® Warning
On June 15, 2011, the FDA issued an urgent health warning to doctors and patients that Actos® may increase the risk of bladder cancer by up to 40%, with long-term users and patients exposed to higher cumulative doses among the groups being at the greatest risk. The FDA now requires that these recent findings and risks be included in the Warnings and Precautions section of the label for Actos® and other pioglitazone-containing medicines.
Despite these alarming statistics, the FDA has chosen not to issue an Actos® recall and the drug remains available in the United States. However, regulatory agencies in France have banned the use of Actos®, and doctors in Germany have been prohibited from prescribing the drug to new patients while the European Medical Association carries out further safety reviews.
Symptoms of Actos®-related bladder cancer may include:
- Blood in urine, sometimes creating a change in urine color
- Frequent urination
- Painful urination
- Urinary tract infection
Actos® and Bladder Cancer: What You Need to Know
Actos® originally received FDA clearance in 1999. At the FDA's request, Takeda Pharmaceuticals agreed to undertake a 10-year epidemiological post-market study in 2002, investigating the questions raised about Actos® and bladder cancer.
An interim analysis of the data produced from the study showed an increased likelihood of bladder cancer developing in patients who took Actos® for the longest periods of time and at the highest cumulative doses. The FDA has informed the public that "...use of the diabetes medication ACTOS (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer."
According to the FDA's warning, "Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk."
No Actos® Recall in the United States Despite Health Risks
The FDA now requires that information about this increased risk be added to the Warnings and Precautions section of the label for Actos® and other pioglitazone-containing medicines. At this time, the Agency has stopped short of issuing an Actos® recall. The FDA "stresses that there is no definitive proof that Actos® causes bladder cancer and that patients who are currently taking it should continue to do so, unless otherwise advised by their healthcare provider."
Read the FDA warning on Actos®
Actos® Lawsuit: Claim Money Damages Now
If you or someone you know has developed bladder cancer after taking Actos®, Actoplus met®, Actoplus met® XR or Duetact®, you may be able to claim money damages and compensation for your current and future medical expenses.
We work on a percentage fee basis. It costs our clients nothing out-of-pocket to move forward with their claim, as our fees are based on any settlement recovered. Contact us today with your Actos® Bladder Cancer questions.
For a free consultation with one of our award-winning lawyers, call us at 1-888-895-2080 or fill out the contact form. Don't wait.
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